Mammography ScreeningNCT07071415
Overdiagnosis and Breast Cancer Screening Decisions
A study testing Breast cancer screening decision aid -- low risk, Breast cancer decision aid -- moderate risk and Breast cancer screening decision aid -- high risk in people with Mammography Screening and Geriatrics, run by Yale University at 1 site in United States.
Trial summary
This is a survey-based study using an online panel. The goal of the study is to understand whether information about overdiagnosis influences breast cancer screening intention among older women. Read more about this study
- Who is it for?
- Ages 70 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mammography Screening, Geriatrics, Decision Aid
- What is being tested?
- Breast cancer screening decision aid -- low risk, Breast cancer decision aid -- moderate risk and Breast cancer screening decision aid -- high risk
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 308 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2025to 20 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 70 and older
- Able to participate in an English-language web-based survey
Who cannot join
- Prior history of breast cancer or ductal carcinoma in situ
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale School of Medicine
New Haven, Connecticut, 06511
About this study
Official title: Breast Cancer Screening Decision Aid
This is a survey-based study using an online panel. The goal of the study is to understand whether information about overdiagnosis influences breast cancer screening intention among older women. Participants are first asked a series of questions about breast cancer screening including their intention to continue screening, knowledge of screening, and beliefs about screening. They are then shown one of three videos about breast cancer screening that contain information about overdiagnosis or a fourth control video that is identical but contains no information about overdiagnosis. Participants are then again asked about screening intention, along with knowledge of screening, overdiagnosis, and questions around trust.
- Conditions
- Mammography Screening, Geriatrics, Decision Aid
- Being tested
- Breast cancer screening decision aid -- low risk, Breast cancer decision aid -- moderate risk, Breast cancer screening decision aid -- high risk, Control condition
- Keywords
- breast cancer screening, health-related beliefs, overdiagnosis, mammography, older women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast cancer screening decision aid -- low riskBehavioural
Participants in this study will view a video-based decision aid that describes the risks and benefits of breast cancer screening for older women. Participants assigned to the low risk of overdiagnosis arm will view a version of the decision aid the describes a low risk of overdiagnosis.
Breast cancer decision aid -- moderate riskBehavioural
Participants in this study will view a video-based decision aid that describes the risks and benefits of breast cancer screening for older women. Participants assigned to the moderate risk of overdiagnosis arm will view a version of the decision aid the describes a moderate risk of overdiagnosis.
Breast cancer screening decision aid -- high riskBehavioural
Participants in this study will view a video-based decision aid that describes the risks and benefits of breast cancer screening for older women. Participants assigned to the high risk of overdiagnosis arm will view a version of the decision aid the describes a high risk of overdiagnosis.
Control conditionOther
Participants in this study will view a video-based decision aid that describes the risks and benefits of breast cancer screening for older women. Participants assigned to the control arm will view a version of the decision aid that does not contain any information about overdiagnosis.
| Study group | Role | What they receive |
|---|---|---|
| Low risk of overdiagnosis | Experimental | Participants in this arm will be shown a decision aid in which risk of overdiagnosis is low. Receives: Behavioral: Breast cancer screening decision aid -- low risk |
| Moderate risk of overdiagnosis | Experimental | Participants in this arm will be shown a decision aid in which risk of overdiagnosis is moderate. Receives: Behavioral: Breast cancer decision aid -- moderate risk |
| High risk of overdiagnosis | Experimental | Participants in this arm will be shown a decision aid in which risk of overdiagnosis is high. Receives: Behavioral: Breast cancer screening decision aid -- high risk |
| Control | Active comparator | Participants in this arm will be shown a video about breast cancer screening that is identical in all ways but contains no information about overdiagnosis. Receives: Other: Control condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants intention to screen
Intention to screen, measured on a 15 point scale. Total score range 1-15, lower score means less likely to screen.
Measured: Day 1
Secondary outcomes (2)
Knowledge of breast cancer screening
Knowledge of screening will be quantified as the proportion of correct answers out of a total possible 7 questions in the pre test and 11 questions in the post test.
Measured: Day 1
Understanding of overdiagnosis
Understanding of overdiagnosis will be quantified as proportion of correct responses out of 3 questions about overdiagnosis.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start19 Aug 2025
- Primary completion20 Oct 2025
- Study completion20 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mammography ScreeningStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 308 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Ilana Richman, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07071415
- Sponsor's protocol ID
- 2000040131
- Other IDs
- K08CA248725
- Status last verified
- Oct 2025
- First submitted
- 21 Jun 2025
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Cancer Screening Decision Aid
- ClinicalTrials.gov ID
- NCT07071415
- Acronym / sponsor ID
- 2000040131
- Conditions
- Mammography Screening, Geriatrics, Decision Aid
- Keywords
- breast cancer screening, health-related beliefs, overdiagnosis, mammography, older women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 308 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- 19 Aug 2025 (actual)
- Primary completion
- 20 Oct 2025 (actual)
- Study completion
- 20 Oct 2025 (actual)
- First posted
- 17 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a survey-based study using an online panel. The goal of the study is to understand whether information about overdiagnosis influences breast cancer screening intention among older women. Participants are first asked a series of questions about breast cancer screening including their intention to continue screening, knowledge of screening, and beliefs about screening. They are then shown one of three videos about breast cancer screening that contain information about overdiagnosis or a fourth control video that is identical but contains no information about overdiagnosis. Participants are then again asked about screening intention, along with knowledge of screening, overdiagnosis, and questions around trust.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low risk of overdiagnosis | Experimental | Behavioral: Breast cancer screening decision aid -- low riskParticipants in this arm will be shown a decision aid in which risk of overdiagnosis is low. |
| Moderate risk of overdiagnosis | Experimental | Behavioral: Breast cancer decision aid -- moderate riskParticipants in this arm will be shown a decision aid in which risk of overdiagnosis is moderate. |
| High risk of overdiagnosis | Experimental | Behavioral: Breast cancer screening decision aid -- high riskParticipants in this arm will be shown a decision aid in which risk of overdiagnosis is high. |
| Control | Active comparator | Other: Control conditionParticipants in this arm will be shown a video about breast cancer screening that is identical in all ways but contains no information about overdiagnosis. |
Who may qualify
- Ages
- 70 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 70 and older
- Able to participate in an English-language web-based survey
Key exclusion criteria (1 listed)
- Prior history of breast cancer or ductal carcinoma in situ
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breast cancer screening decision aid -- low riskParticipants in this study will view a video-based decision aid that describes the risks and benefits of breast cancer screening for older women. Participants assigned to the low risk of overdiagnosis arm will view a version of the decision aid the describes a low risk of overdiagnosis. | Behavioural | Low risk of overdiagnosis |
| Breast cancer decision aid -- moderate riskParticipants in this study will view a video-based decision aid that describes the risks and benefits of breast cancer screening for older women. Participants assigned to the moderate risk of overdiagnosis arm will view a version of the decision aid the describes a moderate risk of overdiagnosis. | Behavioural | Moderate risk of overdiagnosis |
| Breast cancer screening decision aid -- high riskParticipants in this study will view a video-based decision aid that describes the risks and benefits of breast cancer screening for older women. Participants assigned to the high risk of overdiagnosis arm will view a version of the decision aid the describes a high risk of overdiagnosis. | Behavioural | High risk of overdiagnosis |
| Control conditionParticipants in this study will view a video-based decision aid that describes the risks and benefits of breast cancer screening for older women. Participants assigned to the control arm will view a version of the decision aid that does not contain any information about overdiagnosis. | Other | Control |
Primary outcome
Participants intention to screen
Time frame: Day 1
Intention to screen, measured on a 15 point scale. Total score range 1-15, lower score means less likely to screen.
2 secondary outcomes
Knowledge of breast cancer screening
Time frame: Day 1
Understanding of overdiagnosis
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: Yes. Deidentified data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilana Richman, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breast cancer screening decision aid -- low risk, Breast cancer decision aid -- moderate risk and Breast cancer screening decision aid -- high risk in people with Mammography Screening and Geriatrics, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants intention to screen (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.